An interventional study of Submaximal bicycle exercise stress test on Days 1 and 2 in Chronic Fatigue Syndrome, sponsored by Georgetown University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Georgetown University · Not applicable, Interventional, and Basic science
Post-exertional malaise was modeled by having Chronic Fatigue Syndrome (CFS) and sedentary control subjects perform submaximal exercise on 2 consecutive days with objective changes in brain function measured by magnetic resonance imaging (MRI) during cognitive tests before and after the 2 exercise sessions.
Chronic Fatigue Syndrome (CFS) and sedentary control subjects answered on-line advertisements and word-of-mouth communications. Candidates gave verbal informed consent to discuss their medical history during a telephone interview. If the met inclusion and exclusion criteria, they were assigned an log-in code and password to complete an extensive on-line questionnaire, and were scheduled for the 3 day in-patient study.
On the Screening Day subjects completed written informed consent, history and physical, screening blood work, mental status exam, heart rate variability for orthostasis, and dolorimetry for systemic hyperalgesia.
On Exercise Day 1, subjects had magnetic resonance imaging (MRI) for structure (MPRAGE), white matter integrity (diffusion tensor imaging, DTI), and blood oxygenation level dependent (BOLD) analysis during working memory tasks. The tasks were the simple stimulus-response 0-back "see a letter, push a button" task, and the difficult continuous 2-back task "see a string of letters, remember the letters in order, press the button for the letter seen 2 previously ("2-back)".
The submaximal exercise test was performed in identical fashion on day 1 and day 2. Subjects rested on a bicycle ergometer for 5 minutes for baseline cardiopulmonary (VO2) measurements. They began pedalling with resistance increased in step wise fashion until their heart rate reached 70% of predicted maximum heart rate (pHR = 220 - age). They pedaled 25 minutes at 70% or until they felt they had their personal maximum effort (e.g. Borg Exertional Scale 19/20). If they reached 25 minutes, then resistance was increased until they reached 85% of pHR. Continuous EKG, symptoms and VO2 were followed from rest until 5 minutes after peak exercise.
Heart rate variability and symptoms were assessed during recumbent and standing posture to assess orthostatic intolerance.
On Exercise Day 2, the same methods were used, but the order was reversed with the submaximal exercise test first, followed by the identical MRI protocol.
246 studies on the registry are indexed under Fatigue Syndrome, Chronic; 58 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 166 interventional studies indexed under Fatigue Syndrome, Chronic.
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CFS and healthy subjects
Exclusion Criteria:
Any other chronic disease with chronic pain, fatigue and thinking problems (cognitive impairment) that would limit the ability to complete the questionnaires and other tests.
Inclusion and exclusion criteria based on 1994 Center for Disease Control ("Fukuda") criteria of persistent, disabling, moderate to severe fatigue that was relieved by rest, plus at least 4 of the 8 following ancillary features: cognitive dysfunction affecting short term memory or concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbance, and exertional exhaustion (post-exertional malaise). Intervention: Procedure/Surgery: Submaximal bicycle exercise stress test on Days 1 and 2
Procedure: Submaximal bicycle exercise stress test on Days 1 and 2
Subjects who lived a sedentary lifestyle, did not meet Chronic Fatigue Syndrome criteria, and did not have any exclusionary chronic medical, psychiatric or other conditions were our Sedentary Control subjects. By design, this control group included controlled Type II diabetes and thyroid disease, chronic idiopathic fatigue, hypertension (other heart disease excluded) and other stable medical conditions. This variety of subjects were included to prevent ceiling (CFS) vs. floor (control) effects if the control group had totally pristine subjects with zero health issues. Intervention: Procedure/Surgery: Submaximal bicycle exercise stress test on Days 1 and 2
Procedure: Submaximal bicycle exercise stress test on Days 1 and 2
Identical submaximal stress tests were performed on both days to see if Day 1 exercise reduced performance on Day 2, or caused changes between BOLD scans during cognitive testing between Day 1 and Day 2.
Change in blood oxygenation level dependent (BOLD) patterns of brain blood flow during cognitive testing
MRI with cognitive tasks were performed before Day 1 exercise and compared to after the Day 2 exercise.
Time frame: Day 1 (pre-exercise) and Day 2 (after 2nd exercise)
Postural change in heart rate and heart rate variability after exercise
Heart rates were recorded while subjects resting supine for 5 minutes, and during 5 minutes of standing. The change in heart rate (deltaHR) was calculated.
Time frame: Before exercise. 1, 3, 8, 24 and 36 hours after exercise
Pressure-induced pain (systemic hyperalgesia) by dolorimetry
A strain gauge (algometer, dolorimeter) was pressed over 18 traditional fibromyalgia tender point locations at a slow rate \< kg/sec with the subject instructed to tell the operator to stop pushing as soon as they felt pain.
Time frame: 10 am each day for 4 days
No study locations are listed for this record.
Plan to share: Yes — RedCap
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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